title: Belatacept-based regimens are associated with improved cardiovascular and metabolic risk factors compared with cyclosporine in kidney transplant recipients (BENEFIT and BENEFIT-EXT studies).
abstract: BACKGROUND
  Cardiovascular disease, the most common cause of death with a functioning graft among kidney transplant recipients, can be exacerbated by immunosuppressive drugs, particularly the calcineurin inhibitors. Belatacept, a selective co-stimulation blocker, may provide a better cardiovascular/metabolic risk profile than current immunosuppressants.
  
  
  METHODS
  Cardiovascular and metabolic endpoints from two Phase III studies (BENEFIT and BENEFIT-EXT) of belatacept-based regimens in kidney transplant recipients were assessed at month 12. Each study assessed belatacept in more intensive (MI) and less intensive (LI) regimens versus cyclosporine A (CsA). These secondary endpoints included changes in blood pressure, changes in serum lipids, and the incidence of new-onset diabetes after transplant (NODAT).
  
  
  RESULTS
  A total of 1209 patients were randomized and transplanted across the two studies. Mean systolic blood pressure was 6 to 9 mm Hg lower and mean diastolic blood pressure was 3 to 4 mm Hg lower in the MI and LI groups versus CsA (P ≤ 0.002) across both studies at month 12. Non-HDL cholesterol was lower in the belatacept groups versus CsA (P<0.01 MI or LI vs. CsA in each study). Serum triglycerides were lower in the belatacept groups versus CsA (P<0.02 MI or LI vs. CsA in each study). NODAT occurred less often in the belatacept groups versus CsA in a prespecified pooled analysis (P<0.05 MI or LI vs. CsA).
  
  
  CONCLUSIONS
  At month 12, belatacept regimens were associated with better cardiovascular and metabolic risk profiles, with lower blood pressure and serum lipids and less NODAT versus CsA. The overall profile of belatacept will continue to be assessed over the 3-year trials.
authors.affiliation: Nephrology Department, University Hospital Leuven, Leuven, Belgium. yves.vanrenterghem@uz.kuleuven.ac.be
authors.forename: Yves
authors.initials: Y
authors.lastname: Vanrenterghem
authors.forename: Barbara
authors.initials: B
authors.lastname: Bresnahan
authors.forename: Josep
authors.initials: J
authors.lastname: Campistol
authors.forename: Antoine
authors.initials: A
authors.lastname: Durrbach
authors.forename: Josep
authors.initials: J
authors.lastname: Grinyó
authors.forename: Hans-Hellmut
authors.initials: HH
authors.lastname: Neumayer
authors.forename: Philippe
authors.initials: P
authors.lastname: Lang
authors.forename: Christian P
authors.initials: CP
authors.lastname: Larsen
authors.forename: Eduardo
authors.initials: E
authors.lastname: Mancilla-Urrea
authors.forename: José Medina
authors.initials: JM
authors.lastname: Pestana
authors.forename: Alan
authors.initials: A
authors.lastname: Block
authors.forename: Tao
authors.initials: T
authors.lastname: Duan
authors.forename: Alan
authors.initials: A
authors.lastname: Glicklich
authors.forename: Sheila
authors.initials: S
authors.lastname: Gujrathi
authors.forename: Flavio
authors.initials: F
authors.lastname: Vincenti
mesh_terms: D000069594:Abatacept; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D001794:Blood Pressure / Q000187:drug effects; D002318:Cardiovascular Diseases / Q000209:etiology* / Q000503:physiopathology / Q000517:prevention & control; D016572:Cyclosporine / Q000009:adverse effects* / Q000627:therapeutic use*; D003920:Diabetes Mellitus / Q000097:blood / Q000209:etiology* / Q000517:prevention & control; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects* / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000009:adverse effects; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D012307:Risk Factors
chemical_list: D001786:Blood Glucose; D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D008055:Lipids; D000069594:Abatacept; D016572:Cyclosporine